Eli Lilly has revealed results from the SURMOUNT-OSA Phase III clinical trials where tirzepatide demonstrated to lower the severity of moderate-to-severe OSA in obese adults irrespective of positive airway pressure (PAP) therapy status.
The multicentre, randomised, parallel, double-blind, placebo-master protocol assessed tirzepatide’s efficacy and safety against placebo.
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Study 1 enrolled adults with OSA and obesity who were not able or willing to use PAP therapy while those who were and planned to stay on PAP therapy during the trial were part of Study 2.
These patients were randomised into a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) 10mg or 15mg or placebo.
The primary goal was to show tirzepatide’s superiority over placebo in reducing the apnea-hypopnea index (AHI) after 52 weeks.
The studies demonstrated that tirzepatide met all primary and key secondary endpoints.
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By GlobalDataIt showed a mean AHI reduction of up to 62.8%, translating to around 30 fewer events per hour of sleep.
Furthermore, 43% (Study 1) and 51.5% (Study 2) of subjects receiving the tirzepatide treatment at the highest dose achieved disease resolution.
Tirzepatide’s safety profile in the SURMOUNT-OSA studies aligned with previous SURMOUNT and SURPASS trials.
The most common adverse events reported in the studies were related to gastrointestinal complaints, with diarrhoea, nausea and vomiting being the most frequently reported symptoms.
Tirzepatide, known as Zepbound in the US and Mounjaro in other markets, is approved for chronic weight management.
The company filed applications with the US FDA for tirzepatide to treat OSA and obesity, with a decision expected by the end of the year.
Lilly product development senior vice-president Jeff Emmick said: “There are currently no pharmaceutical treatment options to address the underlying cause of OSA, a complex disease that disrupts the daily lives of 80 million people in the US alone and is linked to serious health complications.
“The SURMOUNT-OSA results showed a significant proportion of patients with moderate-to-severe OSA and obesity treated with tirzepatide achieved disease resolution based on predetermined AHI and ESS measures, at which point PAP therapy may not be recommended.”
Recently, the company released data from the Phase II SYNERGY-NASH study of tirzepatide in adults with metabolic dysfunction-associated steatohepatitis and stage 2 or 3 fibrosis.
